FDA issues alert for specific glucose monitoring devices after multiple deaths reported

The U.S. Food and Drug Administration (FDA) is issuing an Early Alert for specific glucose monitoring systems because Abbott Diabetes Care recommends they be removed from the market.

Certain FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor devices may show inaccurate readings, posing a potential safety risk to individuals with diabetes, according to an online release.

Specifically, the devices may display incorrect low-glucose readings, leading to incorrect treatment. However, a recall has not been issued.

The FDA said the company has reported seven deaths and around 736 serious injuries.

However, the Freestyle Libre 3 readers, mobile apps and other products are not affected by this alert.

If you have these products, the FDA recommends verifying that the sensor is impacted. If it is, the company will send you a free replacement.

The products are sold online through the Abbott Diabetes Care website, Amazon Pharmacy, Walgreens locations and at medical supply stores.

The FDA said it is sending an Early Alert for these devices because incorrect glucose readings over an extended period can lead to incorrect treatment decisions.

Early Alerts are issued by the FDA when they are aware of a medical device posing a serious health risk, but has not yet met the standards for a recall. You can learn more here.

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